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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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Device Classification Name transcranial magnetic stimulation system for obsessive-compulsive disorder
De Novo Number DEN170078
Device Name Brainsway Deep Transcranial Magnetic Stimulation (DTMS) System
Requester
brainways ltd.
bynet bldg. p.o.b. 45169
19 hartum str.
har hotzvim,  IL 9777518
Contact ahava stein
Regulation Number882.5802
Classification Product Code
QCI  
Date Received09/29/2017
Decision Date 08/17/2018
Decision granted (DENG)
Classification Advisory Committee Neurology
Review Advisory Committee Neurology
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
Predetermined Change
Control Plan Authorized		 No
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